Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

Drug Development Meetings

Join FDAnews Tuesday, Nov. 29, for "DTC Advertising and Promotion:
Strategies for Adapting to a Changing Environment." In this 90-minute audioconference,
industry insiders, John Kamp and Wayne Pines, brief you on what
to expect and how to prepare. From recent hearings, to industry positions, to
the newest proposals surfacing in Congress, you'll see the DTC controversy from
every angle -- so you can prepare your company to meet all the challenges.
From Nov. 30 Dec. 2, join FDAnews in Bethesda, Md., for the 2nd
Annual FDA Information Management Summit. Learn what the FDA expects, what the
industry advises and what your peers are doing in information management for
2006. Hear from FDA insiders and industry experts, including James Rinaldi,
former FDA chief information officer, and Dr. Scott Gottlieb, FDA deputy
commissioner for medical and scientific affairs.

Nov. 29-30: The EU Clinical Trial Directive

Malvern, Pa.

(610) 688-1708

The Center for Professional Innovation & Education

info@cfpie.com

www.cfpie.com

Nov. 29-Dec. 1: Clinical Drug Development from Strategy to Implementation
-- Oncology as a case study